Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Inflammation; Cataract; Pain

Treatments: Drug: Bromfenac Ophthalmic Solution; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367249

S00124

Details and patient eligibility

About

This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion criteria

• Have known hypersensitivity to bromfenac or to any component of the investigational product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 2 patient groups, including a placebo group

Bromfenac Ophthalmic Solution

Experimental group

Description:

Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.

Treatment:

Drug: Bromfenac Ophthalmic Solution

Placebo

Placebo Comparator group

Description:

One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.

Treatment:

Drug: Placebo